MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INTERLOCK; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	83779
Medical Device Problem Codes	Premature Activation (1484); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/18/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr.: the device was returned for analysis.Visual inspection, the main coil, the pusher wire and an introducer sheath returned for the analysis, and it was observed that the main coil was stretched, bent and detached at the middle section and stretched and bent at the coil arm section.Additionally, it is possible observed presence of blood inside the introducer.The pouch was returned, and it was observed that the pouch information matches with the complaint information.No more damages were observed.Microscope inspection, it was observed that the main coil was stretched, bent and detached at the middle section, and stretched and bent at the coil arm section.Functional inspection could not be performed, because the delivery wire and the main coil are not interlocking.Dimensional inspection for coil arm, zap tip and primary coil outer diameter pass the test.
Event or Problem Description
Reportable based on device analysis completed on 10jul2023.It was reported that the coil deployed in the microcatheter.The target lesion was located in the internal iliac artery.A 5mm x 15cm f-idc 2d coil was selected for embolization.During the procedure, the coil got detached in the direxion microcatheter hub.The procedure was completed with a different device.No complications were reported.However, device analysis revealed that the main coil was detached in the coil arm section.

• Brand Name: INTERLOCK
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORK LIMITED; model farm road; cork ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17430181
• Report Number: 2124215-2023-39354
• Device Sequence Number: 2584786
• Product Code: KRD
• UDI-Device Identifier: 08714729764984
• UDI-Public: 08714729764984
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K132578
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/10/2025
• Device Model Number: 83779
• Device Catalogue Number: 83779
• Device Lot Number: 0029925193
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/10/2023
• Initial Report FDA Received Date: 07/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/10/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MICROCATHETER: DIREXION
• Patient Age: 68 YR
• Patient Sex: Male